Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Me… (NCT07640776) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
40 participantsStarted 2026-09
Plain-language summary
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male, age ≥50 years.
. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
. International Prostate Symptom Score (IPSS) ≥13 at screening.
. Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
. Post-void residual (PVR) ≤250 mL.
. Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).
. Willing and able to comply with all study procedures and follow-up requirements.
. Able to provide written informed consent.
Exclusion criteria
. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
. Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure
Timeframe: From treatment through 6 months post-procedure
2
Mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure
Timeframe: From baseline through 6 months post-procedure